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ZOLEDRONIC ACID

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Zoledronic Acid Adverse Events Reported to the FDA Over Time

How are Zoledronic Acid adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Zoledronic Acid, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Zoledronic Acid is flagged as the suspect drug causing the adverse event.

Most Common Zoledronic Acid Adverse Events Reported to the FDA

What are the most common Zoledronic Acid adverse events reported to the FDA?

Osteonecrosis
1139 (7.43%)
Tooth Extraction
383 (2.5%)
Bone Disorder
338 (2.21%)
Pain
303 (1.98%)
Pain In Jaw
230 (1.5%)
Death
182 (1.19%)
Osteomyelitis
158 (1.03%)
Pyrexia
158 (1.03%)
Fall
146 (.95%)
Impaired Healing
138 (.9%)
Arthralgia
136 (.89%)
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Dyspnoea
127 (.83%)
Infection
120 (.78%)
Nausea
120 (.78%)
Surgery
120 (.78%)
Swelling
116 (.76%)
Hypocalcaemia
101 (.66%)
Sequestrectomy
101 (.66%)
Vomiting
96 (.63%)
Erythema
90 (.59%)
Myalgia
83 (.54%)
Headache
79 (.52%)
Bone Pain
78 (.51%)
Fatigue
77 (.5%)
Malignant Neoplasm Progression
76 (.5%)
Renal Failure Acute
76 (.5%)
Asthenia
75 (.49%)
Malaise
74 (.48%)
Blood Creatinine Increased
73 (.48%)
Bone Debridement
73 (.48%)
Diarrhoea
73 (.48%)
Pain In Extremity
71 (.46%)
Femur Fracture
68 (.44%)
General Physical Health Deteriorati...
66 (.43%)
Debridement
65 (.42%)
Chest Pain
64 (.42%)
Dehydration
64 (.42%)
Pneumonia
64 (.42%)
Gingival Infection
63 (.41%)
Disease Progression
62 (.4%)
Bone Lesion
61 (.4%)
Neoplasm Malignant
60 (.39%)
Back Pain
58 (.38%)
Primary Sequestrum
58 (.38%)
Oral Pain
56 (.37%)
Purulent Discharge
56 (.37%)
Toothache
56 (.37%)
Osteotomy
55 (.36%)
Anaemia
53 (.35%)
Jaw Disorder
53 (.35%)
Hypotension
52 (.34%)
Inflammation
52 (.34%)
Dizziness
50 (.33%)
Renal Failure
50 (.33%)
Oedema Peripheral
49 (.32%)
Syncope
49 (.32%)
Renal Impairment
48 (.31%)
Concomitant Disease Progression
47 (.31%)
Jaw Operation
46 (.3%)
Periodontitis
46 (.3%)
Wound Closure
45 (.29%)
Abdominal Pain
44 (.29%)
Influenza Like Illness
44 (.29%)
Sepsis
44 (.29%)
Chills
43 (.28%)
Fistula
42 (.27%)
Mouth Ulceration
42 (.27%)
Tooth Disorder
42 (.27%)
Drug Ineffective
41 (.27%)
Tooth Abscess
41 (.27%)
Dental Caries
40 (.26%)
Oral Surgery
40 (.26%)
Atrial Fibrillation
39 (.25%)
Bacterial Infection
39 (.25%)
Gait Disturbance
39 (.25%)
Gingivitis
39 (.25%)
Tooth Loss
39 (.25%)
Urinary Tract Infection
39 (.25%)
Weight Decreased
39 (.25%)
Hypertension
38 (.25%)
Neoplasm Progression
36 (.23%)
Osteitis
36 (.23%)
Confusional State
35 (.23%)
Hip Arthroplasty
35 (.23%)
Metastases To Bone
34 (.22%)
Paraesthesia
34 (.22%)
Actinomycosis
33 (.22%)
Blood Urea Increased
33 (.22%)
Eye Pain
33 (.22%)
Hypoaesthesia
33 (.22%)
Loss Of Consciousness
33 (.22%)
Osteolysis
33 (.22%)
Dental Operation
32 (.21%)
Gingival Pain
31 (.2%)
Gingival Swelling
31 (.2%)
Haemoglobin Decreased
31 (.2%)
Hyperbaric Oxygen Therapy
31 (.2%)
Myocardial Infarction
31 (.2%)
Palpitations
31 (.2%)
Abscess
30 (.2%)
Cough
30 (.2%)

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This graph shows the top adverse events submitted to the FDA for Zoledronic Acid, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Zoledronic Acid is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Zoledronic Acid

What are the most common Zoledronic Acid adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Zoledronic Acid, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Zoledronic Acid is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Zoledronic Acid According to Those Reporting Adverse Events

Why are people taking Zoledronic Acid, according to those reporting adverse events to the FDA?

Metastases To Bone
909
Osteoporosis
708
Multiple Myeloma
388
Breast Cancer
285
Osteoporosis Postmenopausal
133
Prostate Cancer
118
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Drug Use For Unknown Indication
106
Osteoporotic Fracture
69
Breast Cancer Metastatic
68
Osteolysis
59
Prophylaxis
46
Product Used For Unknown Indication
41
Hypercalcaemia
40
Prostate Cancer Metastatic
33
Osteitis Deformans
28
Bone Disorder
28
Bone Sarcoma
26
Osteopenia
22
Bone Lesion
19
Lung Neoplasm Malignant
18
Metastasis
17
Bone Pain
14
Hypercalcaemia Of Malignancy
14
Plasmacytoma
13
Metastatic Renal Cell Carcinoma
13
Prostate Cancer Stage Iv
12
Osteoporosis Prophylaxis
10
Renal Cancer
8
Resorption Bone Increased
7
Traumatic Fracture
7
Bone Density Decreased
6
Metastatic Neoplasm
6
Ill-defined Disorder
5
Chemotherapy
5
Adenocarcinoma
4
Cancer Pain
4
Spinal Fracture
4
Neoplasm
4
Osteoarthritis
4
Stem Cell Transplant
4
Ureteric Cancer
4
Neuroblastoma
3
Hypergammaglobulinaemia Benign Mono...
3
Renal Cell Carcinoma
3
Non-hodgkins Lymphoma
3
Renal Cancer Metastatic
3
Breast Cancer Female
3
Hodgkins Disease
3
Pain
3
Ovarian Cancer
2
Spinal Disorder
2

Drug Labels

LabelLabelerEffective
ReclastNovartis Pharmaceuticals Corporation31-AUG-11
ZometaNovartis Pharmaceuticals Corporation11-NOV-12
Zoledronic AcidDr. Reddy's Laboratories Limited21-NOV-12
Zoledronic AcidSun Pharma Global FZE22-NOV-12
Zoledronic AcidSun Pharma Global FZE25-DEC-12
Zoledronic AcidSagent Pharmaceuticals28-JAN-13
Zoledronic AcidJHP Pharmaceuticals, LLC.28-FEB-13
Zoledronic AcidAGILA SPECIALTIES PRIVATE LIMITED09-MAR-13
Zoledronic Acid Heritage Pharmaceuticals Inc.27-MAR-13
Zoledronic AcidHeritage Pharmaceuticals Inc.27-MAR-13
Zoledronic AcidDr.Reddy's Laboratories Ltd28-MAR-13
Zoledronic AcidAmneal-Agila, LLC29-MAR-13

Zoledronic Acid Case Reports

What Zoledronic Acid safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Zoledronic Acid. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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